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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01855256 |
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Date of registration:
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13/05/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Treatment of Hyperhidrosis With Oxybutynin
H²O |
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Scientific title:
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Treatment of Hyperhidrosis With Oxybutynin: a Randomized Controlled Double Blind Against Placebo |
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Date of first enrolment:
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June 2013 |
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Target sample size:
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62 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01855256 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Martine SCHOLLHAMMER, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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ADBO |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age greater than 18 years
- Patient affiliated to social security or beneficiary of such a regime
- Patient able to consent
- Patient with hyperhidrosis, generalized or localized (palmar, plantar, axillary) and
whose score HDSS (Hyperidrosis Disease Severity Scale) is greater than two.
Exclusion Criteria:
- Age less than 18 years
- Patient who can't be followed
- Patient participating in another clinical trial
- Pregnant
- Woman breastfeeding
- Hypersensitivity to oxybutynin or any of the excipients
- Risk of urinary retention related disorders uretroprostatiques
- Intestinal obstruction
- Toxic megacolon
- Intestinal atony
- Severe Ulcerative Colitis
- Myasthenia
- Closure glaucoma the anterior chamber angle or slightly deep
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hyperhidrosis
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Intervention(s)
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Drug: Placebo
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Drug: Oxybutynin
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Primary Outcome(s)
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Evaluation of the effectiveness of oxybutynin in hyperhidrosis
[Time Frame: 6 weeks]
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Secondary Outcome(s)
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Safety evaluation of treatment in this indication
[Time Frame: 6 weeks]
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Secondary ID(s)
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RB 12.035 H²O
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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